KISQALI + AI in Postmenopausal Patients

KISQALI + AI in postmenopausal patients

1L in postmenopausal patients: KISQALI + AI significantly increased mOS benefit vs AI alone. ⁽¹⁾

1-year increase in mOS with KISQALI + AI vs AI alone. *⁽¹⁾
MONALEESA-2: mOS at median 80-month follow-up

* HR 0.76; 95% CI: 0.63–0.93; p=0.008. ⁽¹⁾

MONALEESA-2 study design

Portrait of a smilling black postmenopausal woman representing the MONALEESA-2 breast cancer study design.

MONALEESA-2: N=668, double-blind, placebo-controlled, 1:1 randomised, multicentre, phase III trial in postmenopausal women with HR+/HER2− ABC. As 1L in advanced disease.

No prior endocrine therapy for ABC and no previous systemic chemotherapy for advanced disease. KISQALI 600 mg or placebo orally once daily (3 weeks on/1 week off) + AI (letrozole 2.5 mg continuous).

The primary endpoint was locally assessed PFS, and the key secondary endpoint was OS. Other secondary endpoints included the ORR (complete or partial response), the CBR (overall response plus stable disease lasting 24 weeks or more), safety, and QOL assessments. ⁽²⁾

Abbreviations

1L, first-line; ABC, advanced breast cancer; AI, aromatase inhibitor; CBR, clinical benefit rate; CI, confidence interval; HER2–, human epidermal growth factor receptor 2 negative; HR, hazard ratio; HR+, hormone receptor positive; mOS, median overall survival; ORR, overall response rate; OS, overall survival; QOL, quality of life; PFS, progression-free survival.

References

Hortobagyi GN, et al. N Engl J Med. 2022;386(10):942–950.
Hortobagyi GN, et al. N Engl J Med. 2016;375(18):1738–1748.

Clinical Trial Information

MONALEESA-2 ClinicalTrials.gov number, NCT01958021

Study available online at: https://clinicaltrials.gov

Efficacy